supplementary online content - jama network · symptomatic ae term surveys based on cancer type...

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Supplementary Online Content

Dueck AC, Mendoza TR, Mitchell SA, et al. Validity and reliability of the US National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). JAMA Oncol. Published online August 13, 2015. doi:10.1001/jamaoncol.2015.2639

eFigure 1. Participant Flow Diagram (N=1,100) eFigure 2. Distribution of PRO-CTCAE Item Scores at Visit 1 eFigure 3. Mean PRO-CTCAE Item Scores by Eastern Cooperative Oncology Group (ECOG) Performance Status Score, for PRO-CTCAE Frequency, Severity, and Interference Items at Visit 1 eTable 1. PRO-CTCAE Symptomatic AEs by Electronic Survey eTable 2. PRO-CTCAE Symptomatic AEs by Analysis eTable 3. Construct Validity of PRO-CTCAE Items (all anchors) eTable 4. Test-retest Reliability of 49 Preselected PRO-CTCAE Items (N=80)

This supplementary material has been provided by the authors to give readers additional information about their work.

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eFigure 1. Participant Flow Diagram (N=1,100)

1,100 patients enrolled

975 patients enrolled in the PRIMARY VALIDATION portion of the study

Group A: Patients receiving radiation therapy for ≥21 more

days (N=108)

Excluded from analysis Cancelled participation prior to

Visit 1 (N=7)

Available for analysis at Visit 1 (N=101)

Available for analysis at Visit 1b (next business day after Visit 1;

part of the TEST-RETEST RELIABILITY portion of the

study) (N=80)

Available for analysis at Visit 2 (one week after Visit 1) (N=89)

Visits 3, 4, and 5 (part of the RECALL portion of the study

[reported elsewhere], excluded from the current analysis)

Group B: Patients with 4 or 5 planned consecutive weekly

clinic visits (N=40)

Excluded from analysis Cancelled participation prior to

Visit 1 (N=3)


Available for analysis at Visit 2 (one week after Visit 1) (N=35)

Visits 3, 4, and 5 (part of the RECALL portion of the study

[reported elsewhere], excluded from the current analysis)

Group C: Patients whose planned clinic visits precluded

participation in Group B (N=827)

Excluded from analysis Did not meet eligibility criteria

(N=2) Cancelled participation prior to

Visit 1 (N=23)


Available for analysis at Visit 2 (one to six weeks after Visit 1)

(N=728)

125 patients enrolled in the MODE EQUIVALENCE portion of

the study (results reported elsewhere, excluded from the

current analysis)

N=940

N=852


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eFigure 2. Distribution of PRO-CTCAE Item Scores at Visit 1†

Abbreviations: PRO-CTCAE, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events; F, Frequency; S, Severity; I, Interference with usual or daily activities; A, Amount; P, Presence

†eFigure 2 includes items for the 20 “core” symptomatic AEs selected a priori based on high prevalence in prior National Cancer Institute sponsored clinical trials.

Response options: Frequency: 0=”Never”, 1=”Rarely”, 2=”Occasionally”, 3=”Frequently”, 4=”Almost constantly” Severity: 0=”None”, 1=”Mild”, 2=”Moderate”, 3=”Severe”, 4=”Very severe” Interference: 0=”Not at all”, 1=”A little bit”, 2=”Somewhat”, 3=”Quite a bit”, 4=” Very much” Presence: 0=”No”, 1=”Yes” Amount: 0=”Not at all”, 1=”A little bit”, 2=”Somewhat”, 3=”Quite a bit”, 4=” Very much”


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eFigure 3. Mean PRO-CTCAE Item Scores by Eastern Cooperative Oncology Group (ECOG) Performance Status Score, for PRO-CTCAE Frequency, Severity, and Interference Items at Visit 1†

Abbreviations: PRO-CTCAE, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events; ECOG, Eastern Cooperative Oncology Group; PS, Performance status; F, Frequency; S, Severity; I, Interference with usual or daily activities

†eFigure 3 includes frequency, severity, and interference items for the 20 “core” symptomatic AEs selected a priori based on high prevalence in prior National Cancer Institute sponsored clinical trials. Numerical data for ECOG PS comparisons appear in eTable 3 for all PRO-CTCAE items at both visits.


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eTable 1. PRO-CTCAE Symptomatic AEs by Electronic Survey

PRO-CTCAE Symptomatic AE Term

Surveys Based on Cancer Type Survey for all

patients after 80% were

accrued Breast Survey

Lymphoma/ Myeloma

Survey

Prostate/ Bladder Survey

Lung Survey

Colorectal Survey

Head/Neck and

Esophageal Survey

Other Disease

Site Survey

Anxiety X X X X X X X

Arm/leg swelling X X X X X X X

Constipation X X X X X X X

Decreased appetite X X X X X X X

Dry mouth X X X X X X X

Fatigue X X X X X X X

Hair loss X X X X X X X

Headache X X X X X X X

Insomnia X X X X X X X

Loose stools X X X X X X X

Mouth or throat sores X X X X X X X

Nausea X X X X X X X Numbness/tingling in your hands or feet X X X X X X X

Pain X X X X X X X Problems with concentration X X X X X X X

Problems with tasting food/drink X X X X X X X

Rash X X X X X X X

Sad or unhappy feelings X X X X X X X

Shortness of breath X X X X X X X

Vomiting X X X X X X X

Aching joints X X X X

Aching muscles X X X

Acne X X X

Bed sores X X X

Bloating X X X

Blurry vision X X X

Body odor X X X Breast area enlargement or tenderness X X X

Bruise easily X X X Change in the color of fingernails/toenails X X X X

Cough X X X X

Decreased sexual interest X X X Difficulty getting or keeping an erection X X X

Difficulty swallowing X X X

Dizziness X X X

Dry skin X X X

Ejaculation problems X X X Feelings that nothing could cheer you up X X X X X X X


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Lymphoma/ Myeloma

Survey


Lung Survey

Colorectal Survey

Head/Neck and

Esophageal Survey

Other Disease

Site Survey

Flashing lights in eyes X X X

Frequent urination X X X

Hand-foot syndrome X X X X

Heartburn X X X

Hiccups X X X X

Hives X X X

Hoarse voice X X X

Hot flashes X X X X

Increased passing of gas X X X Increased skin sensitivity to sunlight X X X

Irregular menstrual periods X X X

Itchy skin X X X

Lose any fingernails/toenails X X X X Loss of control of bowel movements X X X

Loss of control of urine X X X Miss an expected menstrual period X X X

Nosebleeds X X X

Pain during vaginal sex X X X

Pain in the abdomen X X X Pain or burning with urination X X X

Pain/swelling/redness at IV X X X

Pounding/racing heartbeat X X X

Problems with memory X X X X Ridges/bumps on fingernails/toenails X X X X

Ringing in ears X X X

Shivering or shaking chills X X X

Skin burns from radiation X X X X X Skin cracking at the corners of your mouth X X X

Spots/lines/floaters) in eyes X X X

Stretch marks X X X

Sudden urges to urinate X X X Took too long to have an orgasm or climax X X X X

Unable to have an orgasm or climax X X X X

Unexpected decrease in sweating X X X

Unexpected or excessive sweating X X X X

Unusual darkening of the skin X X X X

Unusual vaginal discharge X X X


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Lymphoma/ Myeloma

Survey


Lung Survey

Colorectal Survey

Head/Neck and

Esophageal Survey

Other Disease

Site Survey

Urine color change X X X

Vaginal dryness X X X

Voice changes X X X

Watery eyes X X X

Wheezing X X X X

Abbreviations: PRO-CTCAE, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events; AE, adverse event


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eTable 2. PRO-CTCAE Symptomatic AEs by Analysis


Construct validity analyses

Test-retest

reliability Responsive-

ness

Convergent validity analyses Known-groups validity

analyses

Pearson correlation

with QLQ-C30 HRQOL

summary and functioning/ global scales

Pearson correlation with QLQ-

C30 symptom

scales

Comparison between

ECOG PS 0-1 vs 2-4 groups

Comparison between

groups based on cancer

type, treatment, or

other characteristic

Anxiety X X X X X

Arm/leg swelling X X X

Constipation X X X X X X

Decreased appetite X X X X X X

Dry mouth X X X X

Fatigue X X X X X X

Hair loss X X X X

Headache X X X

Insomnia X X X X X X

Loose stools X X X X X X

Mouth or throat sores X X X X X

Nausea X X X X X X Numbness/tingling in your hands or feet X X X X X

Pain X X X X X X Problems with concentration X X X X

Problems with tasting food/drink X X X

Rash X X X X

Sad or unhappy feelings X X X X X

Shortness of breath X X X X X X

Vomiting X X X X X X

Aching joints X X X

Aching muscles X X

Acne X X X

Bed sores X X

Bloating X X X

Blurry vision X X

Body odor X X Breast area enlargement or tenderness X X X

Bruise easily X X Change in the color of fingernails/toenails X X

Cough X X X X

Decreased sexual interest X X Difficulty getting or keeping an erection X X

Difficulty swallowing X X X

Dizziness X X


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Test-retest


ness


analyses

Pearson correlation

with QLQ-C30 HRQOL



C30 symptom

scales

Comparison between


Comparison between


type, treatment, or


Dry skin X X

Ejaculation problems X X Feelings that nothing could cheer you up X X X X

Flashing lights in eyes X X

Frequent urination X X X

Hand-foot syndrome X X X

Heartburn X X X

Hiccups X X X X

Hives X X X

Hoarse voice X X X

Hot flashes X X X

Increased passing of gas X X X Increased skin sensitivity to sunlight X X

Irregular menstrual periods X X X

Itchy skin X X

Lose any fingernails/toenails X X Loss of control of bowel movements X X X

Loss of control of urine X X X Miss an expected menstrual period X X X

Nosebleeds X X X

Pain during vaginal sex X X X

Pain in the abdomen X X X Pain or burning with urination X X X

Pain/swelling/redness at IV X X X

Pounding/racing heartbeat X X

Problems with memory X X X Ridges/bumps on fingernails/toenails X X

Ringing in ears X X X

Shivering or shaking chills X X

Skin burns from radiation X X X X Skin cracking at the corners of your mouth X X X

Spots/lines/floaters) in eyes X X

Stretch marks X X X

Sudden urges to urinate X X X Took too long to have an orgasm or climax X X


10



Test-retest


ness


analyses

Pearson correlation

with QLQ-C30 HRQOL



C30 symptom

scales

Comparison between


Comparison between


type, treatment, or


Unable to have an orgasm or climax X X

Unexpected decrease in sweating X X

Unexpected or excessive sweating X X X

Unusual darkening of the skin X X X X

Unusual vaginal discharge X X X

Urine color change X X X

Vaginal dryness X X X

Voice changes X X X

Watery eyes X X

Wheezing X X X X

Abbreviations: PRO-CTCAE, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire; HRQOL, Health-related quality of life; ECOG, Eastern Cooperative Oncology Group; PS, Performance status


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le F

un

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nin

g0

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0.0

01

Na

use

a (

F)

27

50

Em

otio

na

l Fu

nct

ion

ing

0.2

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0.0

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1


29

PR

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TC

AE

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mV

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NW

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e S

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pto

m L

ev

el G

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ett

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Sy

mp

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up

Me

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nt

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fere

nc

eS

DE

ffe

ct

Siz

e*

EO

RT

C Q

LQ

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0P

ea

rso

n

Co

rre

lati

on

Un

ad

jus

ted

P

-va

lue

Ho

ch

be

rg

P-v

alu

eN

au

sea

(F

)2

75

0C

og

niti

ve F

un

ctio

nin

g0

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<0

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0.0

01

Na

use

a (

F)

27

49

So

cia

l Fu

nct

ion

ing

0.3

5<

0.0

01

<0

.00

1N

au

sea

(F

)2

75

0G

lob

al H

ea

lth S

tatu

s/Q

oL

0.3

1<

0.0

01

<0

.00

1N

au

sea

(F

)2

74

3H

RQ

OL

Su

mm

ary

Sco

re0

.50

<0

.00

1<

0.0

01

Na

use

a (

F)

27

52

Na

use

a a

nd

Vo

miti

ng

0.7

5<

0.0

01

<0

.00

1N

au

sea

(S

)1

83

4E

CO

G P

S 2

-4E

CO

G P

S 0

-10

.36

0.9

70

.37

.<

0.0

01

<0

.00

1N

au

sea

(S

)1

83

4C

he

mo

the

rap

y in

prio

r 2

we

eks

Oth

er

0.3

40

.97

0.3

5.

<0

.00

1<

0.0

01

Na

use

a (

S)

18

34

Cu

rre

ntly

taki

ng

na

use

a m

ed

Oth

er

0.8

80

.88

1.0

0.

<0

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1<

0.0

01

Na

use

a (

S)

18

34

Op

ioid

[na

rco

tic] p

ain

me

d in

prio

r w

ee

kO

the

r0

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0.9

40

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.<

0.0

01

<0

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1N

au

sea

(S

)1

81

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hys

ica

l Fu

nct

ion

ing

0.2

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0.0

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<0

.00

1N

au

sea

(S

)1

81

8R

ole

Fu

nct

ion

ing

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0.0

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<0

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au

sea

(S

)1

81

5E

mo

tion

al F

un

ctio

nin

g0

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0.0

01

Na

use

a (

S)

18

15

Co

gn

itive

Fu

nct

ion

ing

0.3

0<

0.0

01

<0

.00

1N

au

sea

(S

)1

81

5S

oci

al F

un

ctio

nin

g0

.35

<0

.00

1<

0.0

01

Na

use

a (

S)

18

15

Glo

ba

l He

alth

Sta

tus/

Qo

L0

.30

<0

.00

1<

0.0

01

Na

use

a (

S)

18

13

HR

QO

L S

um

ma

ry S

core

0.5

1<

0.0

01

<0

.00

1N

au

sea

(S

)1

81

8N

au

sea

an

d V

om

itin

g0

.73

<0

.00

1<

0.0

01

Na

use

a (

S)

27

75

EC

OG

PS

2-4

EC

OG

PS

0-1

0.3

40

.94

0.3

6.

<0

.00

1<

0.0

01

Na

use

a (

S)

27

75

Ch

em

oth

era

py

in p

rior

2 w

ee

ksO

the

r0

.28

0.9

40

.30

.<

0.0

01

<0

.00

1N

au

sea

(S

)2

77

5C

urr

en

tly ta

kin

g n

au

sea

me

dO

the

r0

.79

0.8

80

.90

.<

0.0

01

<0

.00

1N

au

sea

(S

)2

77

5O

pio

id [n

arc

otic

] pa

in m

ed

in p

rior

we

ek

Oth

er

0.5

60

.91

0.6

1.

<0

.00

1<

0.0

01

Na

use

a (

S)

27

53

Ph

ysic

al F

un

ctio

nin

g0

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<0

.00

1<

0.0

01

Na

use

a (

S)

27

53

Ro

le F

un

ctio

nin

g0

.31

<0

.00

1<

0.0

01

Na

use

a (

S)

27

51

Em

otio

na

l Fu

nct

ion

ing

0.2

9<

0.0

01

<0

.00

1N

au

sea

(S

)2

75

1C

og

niti

ve F

un

ctio

nin

g0

.33

<0

.00

1<

0.0

01

Na

use

a (

S)

27

50

So

cia

l Fu

nct

ion

ing

0.3

7<

0.0

01

<0

.00

1N

au

sea

(S

)2

75

1G

lob

al H

ea

lth S

tatu

s/Q

oL

0.3

5<

0.0

01

<0

.00

1N

au

sea

(S

)2

74

4H

RQ

OL

Su

mm

ary

Sco

re0

.53

<0

.00

1<

0.0

01

Na

use

a (

S)

27

53

Na

use

a a

nd

Vo

miti

ng

0.7

6<

0.0

01

<0

.00

1N

ose

ble

ed

s (F

)1

31

5E

CO

G P

S 2

-4E

CO

G P

S 0

-10

.00

0.6

2-0

.01

.0

.96

0.9

9N

ose

ble

ed

s (F

)1

31

5B

eva

cizu

ma

b in

prio

r 2

we

eks

Oth

er

0.0

60

.61

0.1

0.

0.6

20

.99

No

seb

lee

ds

(F)

13

07

Ph

ysic

al F

un

ctio

nin

g-0

.01

0.8

30

.99

No

seb

lee

ds

(F)

13

07

Ro

le F

un

ctio

nin

g0

.00

0.9

90

.99

No

seb

lee

ds

(F)

13

07

Em

otio

na

l Fu

nct

ion

ing

-0.0

90

.12

0.9

9N

ose

ble

ed

s (F

)1

30

7C

og

niti

ve F

un

ctio

nin

g0

.07

0.2

50

.99

No

seb

lee

ds

(F)

13

07

So

cia

l Fu

nct

ion

ing

-0.0

10

.81

0.9

9N

ose

ble

ed

s (F

)1

30

7G

lob

al H

ea

lth S

tatu

s/Q

oL

-0.0

20

.73

0.9

9N

ose

ble

ed

s (F

)1

30

4H

RQ

OL

Su

mm

ary

Sco

re0

.03

0.6

50

.99

No

seb

lee

ds

(F)

22

78

EC

OG

PS

2-4

EC

OG

PS

0-1

0.0

40

.50

0.0

8.

0.6

30

.99

No

seb

lee

ds

(F)

22

78

Be

vaci

zum

ab

in p

rior

2 w

ee

ksO

the

r0

.07

0.5

00

.15

.0

.48

0.9

9N

ose

ble

ed

s (F

)2

27

3P

hys

ica

l Fu

nct

ion

ing

0.0

00

.96

0.9

9N

ose

ble

ed

s (F

)2

27

3R

ole

Fu

nct

ion

ing

-0.0

20

.68

0.9

9N

ose

ble

ed

s (F

)2

27

1E

mo

tion

al F

un

ctio

nin

g0

.04

0.5

30

.99

No

seb

lee

ds

(F)

22

71

Co

gn

itive

Fu

nct

ion

ing

0.0

10

.93

0.9

9N

ose

ble

ed

s (F

)2

27

1S

oci

al F

un

ctio

nin

g0

.08

0.1

70

.99

No

seb

lee

ds

(F)

22

71

Glo

ba

l He

alth

Sta

tus/

Qo

L0

.02

0.7

40

.99

No

seb

lee

ds

(F)

22

70

HR

QO

L S

um

ma

ry S

core

0.0

20

.76

0.9

9N

ose

ble

ed

s (S

)1

31

4E

CO

G P

S 2

-4E

CO

G P

S 0

-1-0

.04

0.5

1-0

.07

.0

.62

0.9

7N

ose

ble

ed

s (S

)1

31

4B

eva

cizu

ma

b in

prio

r 2

we

eks

Oth

er

0.0

20

.51

0.0

5.

0.8

10

.97

No

seb

lee

ds

(S)

13

06

Ph

ysic

al F

un

ctio

nin

g0

.00

0.9

70

.97

No

seb

lee

ds

(S)

13

06

Ro

le F

un

ctio

nin

g0

.02

0.7

60

.97

No

seb

lee

ds

(S)

13

06

Em

otio

na

l Fu

nct

ion

ing

-0.0

60

.30

.97

No

seb

lee

ds

(S)

13

06

Co

gn

itive

Fu

nct

ion

ing

0.0

60

.27

0.9

7N

ose

ble

ed

s (S

)1

30

6S

oci

al F

un

ctio

nin

g0

.02

0.7

40

.97

No

seb

lee

ds

(S)

13

06

Glo

ba

l He

alth

Sta

tus/

Qo

L0

.01

0.9

10

.97

No

seb

lee

ds

(S)

13

03

HR

QO

L S

um

ma

ry S

core

0.0

40

.46

0.9

7N

ose

ble

ed

s (S

)2

27

7E

CO

G P

S 2

-4E

CO

G P

S 0

-1-0

.01

0.4

7-0

.01

.0

.93

0.9

7N

ose

ble

ed

s (S

)2

27

7B

eva

cizu

ma

b in

prio

r 2

we

eks

Oth

er

0.1

00

.47

0.2

2.

0.3

10

.97

No

seb

lee

ds

(S)

22

72

Ph

ysic

al F

un

ctio

nin

g0

.05

0.4

10

.97

No

seb

lee

ds

(S)

22

72

Ro

le F

un

ctio

nin

g0

.05

0.4

50

.97

No

seb

lee

ds

(S)

22

70

Em

otio

na

l Fu

nct

ion

ing

0.0

80

.21

0.9

7N

ose

ble

ed

s (S

)2

27

0C

og

niti

ve F

un

ctio

nin

g0

.02

0.7

60

.97

No

seb

lee

ds

(S)

22

70

So

cia

l Fu

nct

ion

ing

0.1

10

.08

0.9

7N

ose

ble

ed

s (S

)2

27

0G

lob

al H

ea

lth S

tatu

s/Q

oL

0.0

20

.70

.97

No

seb

lee

ds

(S)

22

69

HR

QO

L S

um

ma

ry S

core

0.0

70

.26

0.9

7N

um

bn

ess

/tin

glin

g in

yo

ur

ha

nd

s o

r fe

et (

S)

18

46

EC

OG

PS

2-4

EC

OG

PS

0-1

0.2

40

.93

0.2

6.

0.0

04

0.0

2N

um

bn

ess

/tin

glin

g in

yo

ur

ha

nd

s o

r fe

et (

S)

18

46

Ta

xan

e/v

inca

alk

alo

id/p

latin

ch

em

oth

era

py

in p

rior

2 w

ee

ksO

the

r0

0.9

40

.0

.97

0.9

7N

um

bn

ess

/tin

glin

g in

yo

ur

ha

nd

s o

r fe

et (

S)

18

29

Ph

ysic

al F

un

ctio

nin

g0

.28

<0

.00

1<

0.0

01

Nu

mb

ne

ss/ti

ng

ling

in y

ou

r h

an

ds

or

fee

t (S

)1

82

9R

ole

Fu

nct

ion

ing

0.2

1<

0.0

01

<0

.00

1N

um

bn

ess

/tin

glin

g in

yo

ur

ha

nd

s o

r fe

et (

S)

18

26

Em

otio

na

l Fu

nct

ion

ing

0.2

0<

0.0

01

<0

.00

1N

um

bn

ess

/tin

glin

g in

yo

ur

ha

nd

s o

r fe

et (

S)

18

26

Co

gn

itive

Fu

nct

ion

ing

0.2

6<

0.0

01

<0

.00

1N

um

bn

ess

/tin

glin

g in

yo

ur

ha

nd

s o

r fe

et (

S)

18

26

So

cia

l Fu

nct

ion

ing

0.1

9<

0.0

01

<0

.00

1N

um

bn

ess

/tin

glin

g in

yo

ur

ha

nd

s o

r fe

et (

S)

18

26

Glo

ba

l He

alth

Sta

tus/

Qo

L0

.19

<0

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1<

0.0

01


30

PR

O-C

TC

AE

Ite

mV

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NW

ors

e S

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pto

m L

ev

el G

rou

pB

ett

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Sy

mp

tom

Le

ve

l Gro

up

Me

an

or

Pe

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nt

Dif

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nc

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DE

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ct

Siz

e*

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RT

C Q

LQ

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0P

ea

rso

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Co

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lati

on

Un

ad

jus

ted

P

-va

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Ho

ch

be

rg

P-v

alu

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um

bn

ess

/tin

glin

g in

yo

ur

ha

nd

s o

r fe

et (

S)

18

24

HR

QO

L S

um

ma

ry S

core

0.3

2<

0.0

01

<0

.00

1N

um

bn

ess

/tin

glin

g in

yo

ur

ha

nd

s o

r fe

et (

S)

27

82

EC

OG

PS

2-4

EC

OG

PS

0-1

0.1

00

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0.1

1.

0.2

60

.77

Nu

mb

ne

ss/ti

ng

ling

in y

ou

r h

an

ds

or

fee

t (S

)2

78

2T

axa

ne

/vin

ca a

lka

loid

/pla

tin c

he

mo

the

rap

y in

prio

r 2

we

eks

Oth

er

00

.91

0.

0.9

60

.97

Nu

mb

ne

ss/ti

ng

ling

in y

ou

r h

an

ds

or

fee

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75

9P

hys

ica

l Fu

nct

ion

ing

0.2

9<

0.0

01

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1N

um

bn

ess

/tin

glin

g in

yo

ur

ha

nd

s o

r fe

et (

S)

27

59

Ro

le F

un

ctio

nin

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<0

.00

1<

0.0

01

Nu

mb

ne

ss/ti

ng

ling

in y

ou

r h

an

ds

or

fee

t (S

)2

75

7E

mo

tion

al F

un

ctio

nin

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<0

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1<

0.0

01

Nu

mb

ne

ss/ti

ng

ling

in y

ou

r h

an

ds

or

fee

t (S

)2

75

7C

og

niti

ve F

un

ctio

nin

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<0

.00

1<

0.0

01

Nu

mb

ne

ss/ti

ng

ling

in y

ou

r h

an

ds

or

fee

t (S

)2

75

6S

oci

al F

un

ctio

nin

g0

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0.0

02

0.0

1N

um

bn

ess

/tin

glin

g in

yo

ur

ha

nd

s o

r fe

et (

S)

27

57

Glo

ba

l He

alth

Sta

tus/

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L0

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<0

.00

1<

0.0

01

Nu

mb

ne

ss/ti

ng

ling

in y

ou

r h

an

ds

or

fee

t (S

)2

75

0H

RQ

OL

Su

mm

ary

Sco

re0

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1<

0.0

01

Nu

mb

ne

ss/ti

ng

ling

in y

ou

r h

an

ds

or

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t (I)

18

46

EC

OG

PS

2-4

EC

OG

PS

0-1

0.2

80

.88

0.3

2.

<0

.00

10

.00

2N

um

bn

ess

/tin

glin

g in

yo

ur

ha

nd

s o

r fe

et (

I)1

84

6T

axa

ne

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ca a

lka

loid

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tin c

he

mo

the

rap

y in

prio

r 2

we

eks

Oth

er

0.0

40

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0.0

5.

0.5

0.5

Nu

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ne

ss/ti

ng

ling

in y

ou

r h

an

ds

or

fee

t (I)

18

29

Ph

ysic

al F

un

ctio

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0.0

01

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mb

ne

ss/ti

ng

ling

in y

ou

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an

ds

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t (I)

18

29

Ro

le F

un

ctio

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0.0

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mb

ne

ss/ti

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ling

in y

ou

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an

ds

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18

26

Em

otio

na

l Fu

nct

ion

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0.2

5<

0.0

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1N

um

bn

ess

/tin

glin

g in

yo

ur

ha

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s o

r fe

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I)1

82

6C

og

niti

ve F

un

ctio

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23

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F)

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Po

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HR

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Po

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S)

13

97

Co

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Fu

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0.2

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1P

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Po

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S)

13

97

Glo

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Po

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g/r

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S)

13

94

HR

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ma

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core

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1P

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35

6R

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0.2

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/ra

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35

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Po

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S)

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56

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Fu

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Po

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S)

23

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t (S

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35

2H

RQ

OL

Su

mm

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Sco

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1<

0.0

01

Pro

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ms

with

co

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ntr

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S)

18

37

EC

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PS

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EC

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PS

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1<

0.0

01

Pro

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ms

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co

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ntr

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n (

S)

18

37

Op

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[na

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tic] p

ain

me

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prio

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(S

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83

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prio

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1P

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(S

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82

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rob

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(S

)1

81

8E

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Pro

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ms

with

co

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ntr

atio

n (

S)

18

18

Co

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Fu

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0.7

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81

8S

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Pro

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ms

with

co

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ntr

atio

n (

S)

18

18

Glo

ba

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Pro

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with

co

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S)

18

16

HR

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rob

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cen

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tion

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CO

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00

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1P

rob

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tra

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77

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we

ek

Oth

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0.4

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01

Pro

ble

ms

with

co

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ntr

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n (

S)

27

76

Sle

ep

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in p

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we

ek

Oth

er

0.3

30

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0.3

7.

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0.0

01

Pro

ble

ms

with

co

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ntr

atio

n (

S)

27

54

Ph

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al F

un

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g0

.39

<0

.00

1<

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01

Pro

ble

ms

with

co

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ntr

atio

n (

S)

27

54

Ro

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un

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g0

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<0

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01

Pro

ble

ms

with

co

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ntr

atio

n (

S)

27

52

Em

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nct

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ing

0.4

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1P

rob

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75

2C

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01

Pro

ble

ms

with

co

nce

ntr

atio

n (

S)

27

51

So

cia

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nct

ion

ing

0.3

5<

0.0

01

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1P

rob

lem

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cen

tra

tion

(S

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75

2G

lob

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ea

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rob

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s w

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cen

tra

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(S

)2

74

5H

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Su

mm

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Sco

re0

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1<

0.0

01

Pro

ble

ms

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co

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ntr

atio

n (

I)1

83

7E

CO

G P

S 2

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CO

G P

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00

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0.0

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1P

rob

lem

s w

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tra

tion

(I)

18

37

Op

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[na

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tic] p

ain

me

d in

prio

r w

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kO

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00

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0.0

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1P

rob

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s w

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cen

tra

tion

(I)

18

37

Sle

ep

aid

in p

rior

we

ek

Oth

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0.1

90

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0.2

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0.0

20

.02

Pro

ble

ms

with

co

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ntr

atio

n (

I)1

82

1P

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ica

l Fu

nct

ion

ing

0.3

8<

0.0

01

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1P

rob

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cen

tra

tion

(I)

18

21

Ro

le F

un

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g0

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1<

0.0

01

Pro

ble

ms

with

co

nce

ntr

atio

n (

I)1

81

8E

mo

tion

al F

un

ctio

nin

g0

.49

<0

.00

1<

0.0

01

Pro

ble

ms

with

co

nce

ntr

atio

n (

I)1

81

8C

og

niti

ve F

un

ctio

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g0

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<0

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1<

0.0

01

Pro

ble

ms

with

co

nce

ntr

atio

n (

I)1

81

8S

oci

al F

un

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nin

g0

.49

<0

.00

1<

0.0

01

Pro

ble

ms

with

co

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ntr

atio

n (

I)1

81

8G

lob

al H

ea

lth S

tatu

s/Q

oL

0.3

4<

0.0

01

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.00

1P

rob

lem

s w

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on

cen

tra

tion

(I)

18

16

HR

QO

L S

um

ma

ry S

core

0.5

5<

0.0

01

<0

.00

1P

rob

lem

s w

ith c

on

cen

tra

tion

(I)

27

73

EC

OG

PS

2-4

EC

OG

PS

0-1

0.4

60

.89

0.5

2.

<0

.00

1<

0.0

01

Pro

ble

ms

with

co

nce

ntr

atio

n (

I)2

77

3O

pio

id [n

arc

otic

] pa

in m

ed

in p

rior

we

ek

Oth

er

0.3

40

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0.3

8.

<0

.00

1<

0.0

01

Pro

ble

ms

with

co

nce

ntr

atio

n (

I)2

77

3S

lee

p a

id in

prio

r w

ee

kO

the

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0.9

00

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.0

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2P

rob

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tion

(I)

27

51

Ph

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un

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1<

0.0

01

Pro

ble

ms

with

co

nce

ntr

atio

n (

I)2

75

1R

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Fu

nct

ion

ing

0.3

9<

0.0

01

<0

.00

1P

rob

lem

s w

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cen

tra

tion

(I)

27

49

Em

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na

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0.4

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1P

rob

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s w

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cen

tra

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(I)

27

49

Co

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Fu

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ion

ing

0.7

0<

0.0

01

<0

.00

1P

rob

lem

s w

ith c

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cen

tra

tion

(I)

27

48

So

cia

l Fu

nct

ion

ing

0.3

7<

0.0

01

<0

.00

1P

rob

lem

s w

ith c

on

cen

tra

tion

(I)

27

49

Glo

ba

l He

alth

Sta

tus/

Qo

L0

.34

<0

.00

1<

0.0

01

Pro

ble

ms

with

co

nce

ntr

atio

n (

I)2

74

2H

RQ

OL

Su

mm

ary

Sco

re0

.52

<0

.00

1<

0.0

01

Pro

ble

ms

with

me

mo

ry (

S)

13

68

EC

OG

PS

2-4

EC

OG

PS

0-1

0.3

20

.79

0.4

0.

0.0

20

.09

Pro

ble

ms

with

me

mo

ry (

S)

12

91

Bre

ast

/Pro

sta

teG

ast

roin

test

ina

l-0

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0.8

2-0

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.0

.18

0.3

8P

rob

lem

s w

ith m

em

ory

(S

)1

36

0P

hys

ica

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nct

ion

ing

0.3

1<

0.0

01

<0

.00

1P

rob

lem

s w

ith m

em

ory

(S

)1

36

0R

ole

Fu

nct

ion

ing

0.3

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0.0

01

<0

.00

1P

rob

lem

s w

ith m

em

ory

(S

)1

36

0E

mo

tion

al F

un

ctio

nin

g0

.32

<0

.00

1<

0.0

01

Pro

ble

ms

with

me

mo

ry (

S)

13

60

Co

gn

itive

Fu

nct

ion

ing

0.6

9<

0.0

01

<0

.00

1P

rob

lem

s w

ith m

em

ory

(S

)1

36

0S

oci

al F

un

ctio

nin

g0

.39

<0

.00

1<

0.0

01

Pro

ble

ms

with

me

mo

ry (

S)

13

60

Glo

ba

l He

alth

Sta

tus/

Qo

L0

.22

<0

.00

1<

0.0

01

Pro

ble

ms

with

me

mo

ry (

S)

13

58

HR

QO

L S

um

ma

ry S

core

0.4

5<

0.0

01

<0

.00

1P

rob

lem

s w

ith m

em

ory

(S

)2

33

8E

CO

G P

S 2

-4E

CO

G P

S 0

-10

.21

0.7

90

.26

.0

.19

0.3

8P

rob

lem

s w

ith m

em

ory

(S

)2

27

2B

rea

st/P

rost

ate

Ga

stro

inte

stin

al

0.0

90

.84

0.1

1.

0.4

90

.49

Pro

ble

ms

with

me

mo

ry (

S)

23

25

Ph

ysic

al F

un

ctio

nin

g0

.26

<0

.00

1<

0.0

01


34

PR

O-C

TC

AE

Ite

mV

isit

NW

ors

e S

ym

pto

m L

ev

el G

rou

pB

ett

er

Sy

mp

tom

Le

ve

l Gro

up

Me

an

or

Pe

rce

nt

Dif

fere

nc

eS

DE

ffe

ct

Siz

e*

EO

RT

C Q

LQ

-C3

0P

ea

rso

n

Co

rre

lati

on

Un

ad

jus

ted

P

-va

lue

Ho

ch

be

rg

P-v

alu

eP

rob

lem

s w

ith m

em

ory

(S

)2

32

5R

ole

Fu

nct

ion

ing

0.2

1<

0.0

01

<0

.00

1P

rob

lem

s w

ith m

em

ory

(S

)2

32

6E

mo

tion

al F

un

ctio

nin

g0

.30

<0

.00

1<

0.0

01

Pro

ble

ms

with

me

mo

ry (

S)

23

26

Co

gn

itive

Fu

nct

ion

ing

0.7

5<

0.0

01

<0

.00

1P

rob

lem

s w

ith m

em

ory

(S

)2

32

5S

oci

al F

un

ctio

nin

g0

.28

<0

.00

1<

0.0

01

Pro

ble

ms

with

me

mo

ry (

S)

23

26

Glo

ba

l He

alth

Sta

tus/

Qo

L0

.13

0.0

20

.08

Pro

ble

ms

with

me

mo

ry (

S)

23

20

HR

QO

L S

um

ma

ry S

core

0.3

8<

0.0

01

<0

.00

1P

rob

lem

s w

ith m

em

ory

(I)

13

68

EC

OG

PS

2-4

EC

OG

PS

0-1

0.3

70

.85

0.4

3.

0.0

10

.05

Pro

ble

ms

with

me

mo

ry (

I)1

29

1B

rea

st/P

rost

ate

Ga

stro

inte

stin

al

-0.0

80

.89

-0.0

9.

0.5

70

.57

Pro

ble

ms

with

me

mo

ry (

I)1

36

0P

hys

ica

l Fu

nct

ion

ing

0.3

1<

0.0

01

<0

.00

1P

rob

lem

s w

ith m

em

ory

(I)

13

60

Ro

le F

un

ctio

nin

g0

.29

<0

.00

1<

0.0

01

Pro

ble

ms

with

me

mo

ry (

I)1

36

0E

mo

tion

al F

un

ctio

nin

g0

.39

<0

.00

1<

0.0

01

Pro

ble

ms

with

me

mo

ry (

I)1

36

0C

og

niti

ve F

un

ctio

nin

g0

.60

<0

.00

1<

0.0

01

Pro

ble

ms

with

me

mo

ry (

I)1

36

0S

oci

al F

un

ctio

nin

g0

.48

<0

.00

1<

0.0

01

Pro

ble

ms

with

me

mo

ry (

I)1

36

0G

lob

al H

ea

lth S

tatu

s/Q

oL

0.2

5<

0.0

01

<0

.00

1P

rob

lem

s w

ith m

em

ory

(I)

13

58

HR

QO

L S

um

ma

ry S

core

0.4

5<

0.0

01

<0

.00

1P

rob

lem

s w

ith m

em

ory

(I)

23

38

EC

OG

PS

2-4

EC

OG

PS

0-1

0.2

50

.78

0.3

2.

0.1

0.3

1P

rob

lem

s w

ith m

em

ory

(I)

22

72

Bre

ast

/Pro

sta

teG

ast

roin

test

ina

l0

.17

0.8

20

.20

.0

.19

0.3

9P

rob

lem

s w

ith m

em

ory

(I)

23

25

Ph

ysic

al F

un

ctio

nin

g0

.25

<0

.00

1<

0.0

01

Pro

ble

ms

with

me

mo

ry (

I)2

32

5R

ole

Fu

nct

ion

ing

0.2

4<

0.0

01

<0

.00

1P

rob

lem

s w

ith m

em

ory

(I)

23

26

Em

otio

na

l Fu

nct

ion

ing

0.3

4<

0.0

01

<0

.00

1P

rob

lem

s w

ith m

em

ory

(I)

23

26

Co

gn

itive

Fu

nct

ion

ing

0.6

2<

0.0

01

<0

.00

1P

rob

lem

s w

ith m

em

ory

(I)

23

25

So

cia

l Fu

nct

ion

ing

0.2

9<

0.0

01

<0

.00

1P

rob

lem

s w

ith m

em

ory

(I)

23

26

Glo

ba

l He

alth

Sta

tus/

Qo

L0

.16

0.0

03

0.0

1P

rob

lem

s w

ith m

em

ory

(I)

23

20

HR

QO

L S

um

ma

ry S

core

0.3

7<

0.0

01

<0

.00

1P

rob

lem

s w

ith ta

stin

g fo

od

/drin

k (S

)1

83

9E

CO

G P

S 2

-4E

CO

G P

S 0

-10

.31

1.1

60

.27

.0

.00

30

.00

3P

rob

lem

s w

ith ta

stin

g fo

od

/drin

k (S

)1

82

3P

hys

ica

l Fu

nct

ion

ing

0.2

5<

0.0

01

<0

.00

1P

rob

lem

s w

ith ta

stin

g fo

od

/drin

k (S

)1

82

3R

ole

Fu

nct

ion

ing

0.3

0<

0.0

01

<0

.00

1P

rob

lem

s w

ith ta

stin

g fo

od

/drin

k (S

)1

82

0E

mo

tion

al F

un

ctio

nin

g0

.24

<0

.00

1<

0.0

01

Pro

ble

ms

with

tast

ing

foo

d/d

rink

(S)

18

20

Co

gn

itive

Fu

nct

ion

ing

0.2

7<

0.0

01

<0

.00

1P

rob

lem

s w

ith ta

stin

g fo

od

/drin

k (S

)1

82

0S

oci

al F

un

ctio

nin

g0

.32

<0

.00

1<

0.0

01

Pro

ble

ms

with

tast

ing

foo

d/d

rink

(S)

18

20

Glo

ba

l He

alth

Sta

tus/

Qo

L0

.22

<0

.00

1<

0.0

01

Pro

ble

ms

with

tast

ing

foo

d/d

rink

(S)

18

18

HR

QO

L S

um

ma

ry S

core

0.4

4<

0.0

01

<0

.00

1P

rob

lem

s w

ith ta

stin

g fo

od

/drin

k (S

)2

77

5E

CO

G P

S 2

-4E

CO

G P

S 0

-10

.36

1.2

00

.30

.0

.00

20

.00

3P

rob

lem

s w

ith ta

stin

g fo

od

/drin

k (S

)2

75

3P

hys

ica

l Fu

nct

ion

ing

0.2

5<

0.0

01

<0

.00

1P

rob

lem

s w

ith ta

stin

g fo

od

/drin

k (S

)2

75

3R

ole

Fu

nct

ion

ing

0.2

9<

0.0

01

<0

.00

1P

rob

lem

s w

ith ta

stin

g fo

od

/drin

k (S

)2

75

1E

mo

tion

al F

un

ctio

nin

g0

.18

<0

.00

1<

0.0

01

Pro

ble

ms

with

tast

ing

foo

d/d

rink

(S)

27

51

Co

gn

itive

Fu

nct

ion

ing

0.2

2<

0.0

01

<0

.00

1P

rob

lem

s w

ith ta

stin

g fo

od

/drin

k (S

)2

75

0S

oci

al F

un

ctio

nin

g0

.34

<0

.00

1<

0.0

01

Pro

ble

ms

with

tast

ing

foo

d/d

rink

(S)

27

51

Glo

ba

l He

alth

Sta

tus/

Qo

L0

.29

<0

.00

1<

0.0

01

Pro

ble

ms

with

tast

ing

foo

d/d

rink

(S)

27

44

HR

QO

L S

um

ma

ry S

core

0.4

3<

0.0

01

<0

.00

1R

ash

(P

)1

82

1E

CO

G P

S 2

-4E

CO

G P

S 0

-1-2

.31

%-0

.06

.0

.51

0.9

3R

ash

(P

)1

82

1R

ad

iatio

n th

era

py

in p

rior

2 w

ee

ksO

the

r2

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%0

.07

.0

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.93

Ra

sh (

P)

18

05

Ph

ysic

al F

un

ctio

nin

g0

.03

0.4

20

.93

Ra

sh (

P)

18

05

Ro

le F

un

ctio

nin

g0

.03

0.4

20

.93

Ra

sh (

P)

18

02

Em

otio

na

l Fu

nct

ion

ing

0.0

10

.70

.93

Ra

sh (

P)

18

02

Co

gn

itive

Fu

nct

ion

ing

0.0

40

.26

0.9

3R

ash

(P

)1

80

2S

oci

al F

un

ctio

nin

g0

.04

0.2

30

.93

Ra

sh (

P)

18

02

Glo

ba

l He

alth

Sta

tus/

Qo

L0

.02

0.5

10

.93

Ra

sh (

P)

18

00

HR

QO

L S

um

ma

ry S

core

0.0

40

.24

0.9

3R

ash

(P

)2

75

6E

CO

G P

S 2

-4E

CO

G P

S 0

-1-0

.67

%-0

.02

.0

.87

0.9

3R

ash

(P

)2

75

6R

ad

iatio

n th

era

py

in p

rior

2 w

ee

ksO

the

r7

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%0

.18

.0

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0.2

1R

ash

(P

)2

73

5P

hys

ica

l Fu

nct

ion

ing

0.0

50

.21

0.9

3R

ash

(P

)2

73

5R

ole

Fu

nct

ion

ing

0.0

40

.31

0.9

3R

ash

(P

)2

73

3E

mo

tion

al F

un

ctio

nin

g-0

.02

0.5

0.9

3R

ash

(P

)2

73

3C

og

niti

ve F

un

ctio

nin

g0

.03

0.4

70

.93

Ra

sh (

P)

27

32

So

cia

l Fu

nct

ion

ing

0.0

40

.31

0.9

3R

ash

(P

)2

73

3G

lob

al H

ea

lth S

tatu

s/Q

oL

0.0

30

.43

0.9

3R

ash

(P

)2

72

6H

RQ

OL

Su

mm

ary

Sco

re0

.00

0.9

30

.93

Rid

ge

s/b

um

ps

on

fin

ge

rna

ils/to

en

ails

(P

)1

48

3E

CO

G P

S 2

-4E

CO

G P

S 0

-1-1

.40

%-0

.04

.0

.78

0.8

9R

idg

es/

bu

mp

s o

n fi

ng

ern

ails

/toe

na

ils (

P)

14

68

Ph

ysic

al F

un

ctio

nin

g0

.06

0.1

70

.89

Rid

ge

s/b

um

ps

on

fin

ge

rna

ils/to

en

ails

(P

)1

46

8R

ole

Fu

nct

ion

ing

-0.0

10

.89

0.8

9R

idg

es/

bu

mp

s o

n fi

ng

ern

ails

/toe

na

ils (

P)

14

68

Em

otio

na

l Fu

nct

ion

ing

-0.0

30

.58

0.8

9R

idg

es/

bu

mp

s o

n fi

ng

ern

ails

/toe

na

ils (

P)

14

68

Co

gn

itive

Fu

nct

ion

ing

0.1

10

.01

0.2

2R

idg

es/

bu

mp

s o

n fi

ng

ern

ails

/toe

na

ils (

P)

14

68

So

cia

l Fu

nct

ion

ing

-0.0

10

.89

0.8

9R

idg

es/

bu

mp

s o

n fi

ng

ern

ails

/toe

na

ils (

P)

14

68

Glo

ba

l He

alth

Sta

tus/

Qo

L0

.01

0.8

60

.89

Rid

ge

s/b

um

ps

on

fin

ge

rna

ils/to

en

ails

(P

)1

46

5H

RQ

OL

Su

mm

ary

Sco

re0

.03

0.4

90

.89

Rid

ge

s/b

um

ps

on

fin

ge

rna

ils/to

en

ails

(P

)2

43

9E

CO

G P

S 2

-4E

CO

G P

S 0

-1-5

.90

%-0

.15

.0

.35

0.8

9R

idg

es/

bu

mp

s o

n fi

ng

ern

ails

/toe

na

ils (

P)

24

23

Ph

ysic

al F

un

ctio

nin

g0

.06

0.2

0.8

9R

idg

es/

bu

mp

s o

n fi

ng

ern

ails

/toe

na

ils (

P)

24

23

Ro

le F

un

ctio

nin

g0

.03

0.4

90

.89

Rid

ge

s/b

um

ps

on

fin

ge

rna

ils/to

en

ails

(P

)2

42

2E

mo

tion

al F

un

ctio

nin

g0

.04

0.4

10

.89

Rid

ge

s/b

um

ps

on

fin

ge

rna

ils/to

en

ails

(P

)2

42

2C

og

niti

ve F

un

ctio

nin

g0

.06

0.2

30

.89

Rid

ge

s/b

um

ps

on

fin

ge

rna

ils/to

en

ails

(P

)2

42

1S

oci

al F

un

ctio

nin

g0

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0.6

60

.89

Rid

ge

s/b

um

ps

on

fin

ge

rna

ils/to

en

ails

(P

)2

42

2G

lob

al H

ea

lth S

tatu

s/Q

oL

0.0

80

.08

0.8

9


35

PR

O-C

TC

AE

Ite

mV

isit

NW

ors

e S

ym

pto

m L

ev

el G

rou

pB

ett

er

Sy

mp

tom

Le

ve

l Gro

up

Me

an

or

Pe

rce

nt

Dif

fere

nc

eS

DE

ffe

ct

Siz

e*

EO

RT

C Q

LQ

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ea

rso

n

Co

rre

lati

on

Un

ad

jus

ted

P

-va

lue

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ch

be

rg

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alu

eR

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bu

mp

s o

n fi

ng

ern

ails

/toe

na

ils (

P)

24

15

HR

QO

L S

um

ma

ry S

core

0.0

60

.21

0.8

9R

ing

ing

in e

ars

(S

)1

29

4E

CO

G P

S 2

-4E

CO

G P

S 0

-10

.19

0.7

90

.25

.0

.21

0.6

7R

ing

ing

in e

ars

(S

)1

19

1H

ea

d/N

eck

Pro

sta

te/B

lad

de

r0

.29

0.7

80

.38

.0

.01

0.1

2R

ing

ing

in e

ars

(S

)1

29

1P

hys

ica

l Fu

nct

ion

ing

0.0

60

.33

0.6

7R

ing

ing

in e

ars

(S

)1

29

1R

ole

Fu

nct

ion

ing

0.1

80

.00

20

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Rin

gin

g in

ea

rs (

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12

88

Em

otio

na

l Fu

nct

ion

ing

0.1

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0.0

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0.0

1R

ing

ing

in e

ars

(S

)1

28

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niti

ve F

un

ctio

nin

g0

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0.0

20

.15

Rin

gin

g in

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rs (

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12

88

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cia

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nct

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0.2

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0.0

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0.0

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Rin

gin

g in

ea

rs (

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12

88

Glo

ba

l He

alth

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tus/

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L0

.13

0.0

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.15

Rin

gin

g in

ea

rs (

S)

12

86

HR

QO

L S

um

ma

ry S

core

0.2

5<

0.0

01

<0

.00

1R

ing

ing

in e

ars

(S

)2

26

2E

CO

G P

S 2

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CO

G P

S 0

-1-0

.01

0.7

4-0

.02

.0

.94

0.9

4R

ing

ing

in e

ars

(S

)2

17

5H

ea

d/N

eck

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sta

te/B

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de

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.37

.0

.01

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5R

ing

ing

in e

ars

(S

)2

25

9P

hys

ica

l Fu

nct

ion

ing

0.0

60

.31

0.6

7R

ing

ing

in e

ars

(S

)2

25

9R

ole

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nct

ion

ing

0.1

50

.01

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ing

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in e

ars

(S

)2

25

8E

mo

tion

al F

un

ctio

nin

g0

.19

0.0

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0.0

3R

ing

ing

in e

ars

(S

)2

25

8C

og

niti

ve F

un

ctio

nin

g0

.13

0.0

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ing

ing

in e

ars

(S

)2

25

7S

oci

al F

un

ctio

nin

g0

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pto

m L

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ett

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mp

tom

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ve

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up

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or

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nt

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be

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l He

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ng

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5E

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tien

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tco

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f th

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mo

n T

erm

ino

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nd

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est

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eve

rity;

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terf

ere

nce

with

usu

al o

r d

aily

act

iviti

es;

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rese

nce

/ab

sen

ce; A

, Am

ou

nt;

EC

OG

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ste

rn C

oo

pe

rativ

e O

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log

y G

rou

p P

erf

orm

an

ce S

tatu

s; Q

oL

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alit

y o

f Life

; HR

QO

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ea

lth-r

ela

ted

qu

alit

y o

f life

* C

oh

en

's d

for

gro

up

diff

ere

nce

s; C

oh

en

's h

for

diff

ere

nce

s in

pro

po

rtio

ns

** N

ot c

on

sid

ere

d a

s e

vid

en

ce o

f va

lidity

be

cau

se d

irect

ion

of e

ffect

is th

e o

pp

osi

te o

f th

at h

ypo

the

size

d1

- H

an

d-f

oo

t syn

dro

me

-ind

uci

ng

ch

em

oth

era

pie

s in

clu

de

ca

pe

cita

bin

e, f

luo

rou

raci

l, su

niti

nib

, an

d s

ora

fen

ib2

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kin

-re

act

ion

ch

em

oth

era

pie

s in

clu

de

ep

ide

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l gro

wth

fact

or

rece

pto

r in

hib

itors

, do

ceta

xel,

ge

mci

tab

ine

, pa

clita

xel,

an

d p

em

etr

exe

d3

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rita

nt c

he

mo

the

rap

ies

incl

ud

e b

leo

myc

in, b

ort

ezo

mib

, ca

rbo

pla

tin, c

yclo

ph

osp

ha

mid

e, c

yta

rab

ine

, da

carb

azi

ne

, da

un

oru

bic

in, d

oce

taxe

l, d

oxo

rub

icin

, eto

po

sid

e, f

luo

rou

raci

l, g

em

cita

bin

e, i

fosf

am

ide

, irin

ote

can

, na

b-p

acl

itaxe

l, o

xalip

latin

,p

acl

itaxe

l, to

po

teca

n, a

nd

tra

stu

zum

ab


43

eTable 4. Test-retest Reliability for 49 Preselected PRO-CTCAE Items (N=80)

PRO-CTCAE Symptomatic AE Term Intra-class Correlation Coefficient Frequency Severity Interference Presence Amount

Anxiety 0.78 0.69 0.83 - - Arm/leg swelling 0.86 0.68 0.64 - - Constipation - 0.83 - - - Cough - 0.74 0.53 - - Decreased appetite - 0.80 0.80 - - Dry mouth - 0.74 - - - Fatigue - 0.77 0.79 - - Feelings that nothing could cheer you up 0.70 0.75 0.72 - - Hair loss - - - - 0.96 Headache 0.80 0.78 0.78 - - Hiccups 0.69 0.71 - - - Insomnia - 0.64 0.72 - - Loose stools 0.54 - - - - Mouth or throat sores - 0.82 0.81 - - Nausea 0.80 0.84 - - - Numbness/tingling in your hands or feet - 0.80 0.55 - - Pain 0.83 0.82 0.84 - - Problems with concentration - 0.74 0.70 - - Problems with tasting food/drink - 0.84 - - - Rash - - - 0.86 - Sad or unhappy feelings 0.72 0.61 0.76 - - Shortness of breath - 0.70 0.66 - - Skin burns from radiation - 0.65 - - - Unusual darkening of the skin - - - 0.73 - Vomiting 0.81 0.79 - - - Wheezing 0.65

Abbreviations: PRO-CTCAE, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events; AE, adverse event


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